Archive Management Study Closure Services
Are your data managers spending hours on administrative duties during study closeout? Is your team stressed out on the eve of an audit? Ensure compliance, shorten timelines, and manage the entire process more efficiently with our archiving solution!
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Managing the archive process and the Trial Master File (TMF) should be a walk in the park for your team. But all too often study closeout is characterized by compliance concerns, delayed timelines, communication barriers, and severe headaches!
Now more than ever it is important to comply with industry regulations to avoid costly fines and other damages. Yet teams often lack the ability to easily manage the administrative ends of the process and the TMF. As a result, it is tempting to take shortcuts to get the job done. This scenario exposes the team and their company to uncontrolled content and regulatory risk, and adds hours of unnecessary administrative work as teams misplace documents or struggle to retrieve authorization.
We’ve developed our Archive Management Services in collaboration with our clients to solve these issues. This validated system will simplify the study closeout process, deliver compliant solutions, and save your team valuable time.
Your Team Will Enjoy:
Confidence with Compliance
Regulations indicate that sites should have ready-access to trial data for purposes of review at the site. Our cloud-based system allows site data to be extracted, organized and delivered directly to sites. Imperial Graphics works directly with your electronic data capture (EDC) providers to create electronic site archives and TMFs via the EDC data store or data received through FTP, CD and various other media. Throughout the process, our team manages the user acceptance testing and quality control.
Seamless Project Management
Does your team struggle to contact sites and obtain authorization? Do you find that paper documentation goes missing? Let us take the administrative burden off your shoulders with our experienced project management capabilities! We implement a systematic, automated contact schedule to achieve the appropriate documentation from all sites ─ electronically! This expedites the administrative process and allows you to close out sites ahead of schedule.
A Simplified Process
The study closure process is now easier than ever! We have built an intuitive online management portal that gives data managers 24/7 access to critical files from anywhere around the globe. This online portal guides data personnel through the process in a compliant and efficient manner. The electronic Trial Master Files and electronic Investigator Site Files can be generated directly from EDC data in a matter of minutes and distributed to sites in two weeks or less. Clients who’ve adopted our system consistently praise its simplicity and efficiencies.
We work in a truly complex global environment – consider study sites, CROs and a multitude of other affiliates around the globe that need immediate access to study data. By leveraging our cloud-based solution, companies can remove layers of complication, communication barriers, and time zone differences to ensure quick, secure access for study teams everywhere. Stop dealing with disparate systems and processes. Eliminate redundancies. Drive efficiency, instead. Our contained system provides a single data source repository that data managers can easily access from anywhere, anytime.
Our clients frequently find themselves weeks ahead of timelines. Our easy-to-use system helps data teams get the job done right the first time, every time. Certain steps of the process are now automated and there are checks in place to ensure completeness and to move the process along weeks ahead of schedule. Our typical turnaround time is two weeks or less!
Employing cost-effective solutions that meet company needs is paramount for any decision-maker. Our process allows you to close sites weeks ahead of schedule, saving you from increased costs. The intuitive online interface and cloud-based platform allow for global online access without expensive and faulty hardware or software. Our goal is to provide a compliant, streamlined service that saves data managers time, simplifies site and TMF compliance, and ultimately reflects positively on the bottom line.
Guarantee the security of your electronic archives by encrypting or password-protecting your files. Our system has been documented, tested and computer- validated to perform as advertised. Your archives will remain secure and readily accessible for 100 years.